NDC 0143-9768-01 - Ceftriaxone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0143-9768
Requested NDC: 0143-9768-01
Package NDCs from labels: 0143-9768-01, 0143-9768-46
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2019-12-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ceftriaxone for Injection	Hikma Pharmaceuticals USA Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0143-9768-46	2020-09-27	C162847	48780-1	ab0e2407-33df-f274-e053-dbdaa90a6471	Ceftriaxone for Injection
0143-9768-46	2020-09-25	C162847	48780-1	ab0e2407-33df-f274-e053-dbdaa90a6471	Ceftriaxone for Injection
0143-9768-46	2020-07-22	C162847	48780-1	ab0e2407-33df-f274-e053-dbdaa90a6471	Ceftriaxone for Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9768-01	Ceftriaxone	100 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	100		8
0143-9768-46	Ceftriaxone	1 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9768	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	8	Legacy NDC, 2 package rows	20191231_e38c48f6-4d07-422b-9bb2-3c1025946e86.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFTRIAXONE SODIUM	ACTIVE INGREDIENT	023Z5BR09K	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	7
CEFTRIAXONE	ACTIVE MOIETY	75J73V1629	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	ff8e830a-c288-46fb-9e19-ec2017943c07	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
ceftriaxone	CEFTRIAXONE	Sagent Pharmaceuticals	5cf93bc5-9e4c-4734-bc02-c7d0ac071022	2023-11-08	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone	CEFTRIAXONE	Fresenius Kabi USA, LLC	7ea1db43-40fa-417b-8911-ae98092070a0	2023-09-30	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Asclemed USA, Inc.	f01cf0e5-caaf-4759-ba21-50f3aceff523	2023-09-02	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	5116231f-82d1-44be-b08e-560c9a50e5c5	2023-08-31	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	ac03a72c-0e35-40f9-b7fc-081badb5f19c	2023-01-28	Warnings, Adverse reactions	Exact identifier rxcui: 309090 unii: 023Z5BR09K
Ceftriaxone	CEFTRIAXONE SODIUM	Samson Medical Technologies, LLC	5cd2d96f-83e5-4326-ae87-d0ede4ba493a	2023-01-15	Warnings, Adverse reactions	Exact identifier rxcui: 309090 unii: 023Z5BR09K
Ceftriaxone	CEFTRIAXONE	Proficient Rx LP	fcf401df-bcdc-4773-a63b-9741c0f74b3d	2022-11-01	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	a25ab5ea-c46d-4562-8f7e-0ccffc2ab069	2022-10-01	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	42ba7a9d-7d2b-4eac-af59-897151a8c924	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	9d1f630b-e759-4395-9d01-ddc90e4fea75	2022-03-09	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	67153914-16bc-490d-82d7-638061618467	2022-01-13	Warnings, Adverse reactions	Exact identifier unii: 023Z5BR09K
c4d2239c-f0a2-4ef8-853c-3ce83490d7e1			e38c48f6-4d07-422b-9bb2-3c1025946e86	2019-12-30	Warnings, Adverse reactions	Exact identifier spl id: c4d2239c-f0a2-4ef8-853c-3ce83490d7e1 spl set id: e38c48f6-4d07-422b-9bb2-3c1025946e86
Ceftriaxone	CEFTRIAXONE	Hikma Pharmaceuticals USA Inc.	1f8776bd-4f5b-427a-849a-6b8338f7997d	2019-04-24	Warnings, Adverse reactions	Exact identifier rxcui: 309090 unii: 023Z5BR09K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.